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FDA 510(k) Application Details - K013513
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K013513
Device Name
Arthroscope
Applicant
PAIN CONCEPTS, INC.
8001 IRVINE CENTER DR.
4TH FLOOR
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact
RUSSELL PFLUEGER
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/22/2001
Decision Date
01/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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